# Senior CRA - Sponsor dedicated

**Company**: Syneos Health
**Location**: DEU-Remote
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/DEU-Remote/Senior-CRA----Sponsor-dedicated---Home-Based-Germany_25114126-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_2586d2f1-ef2

## Description

Syneos Health is seeking a Senior CRA - Sponsor dedicated to work from home in Germany.

The Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions they shape.

**Job Responsibilities**

- Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.

- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.

- Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site.

- Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes, conducts Source Document Review of appropriate site source documents and medical records.

- May perform investigational product (IP) inventory, reconciliation and reviews storage and security.

- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.

- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.

- Understands project scope, budgets, and timelines for own and others’ activities in the clinical team.

- May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.

- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.

- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

- May provide direct supervision, training and/or mentorship to more junior level CRAs.

**Qualifications**

- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience

- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

- Preferably oncology experience

- Fluency in German, proficient in speaking and writing English

- Experience in Oncology

- A positive and can-do attitude. Excellent communication, presentation and interpersonal skills.

- Ability to manage required travel of up to 75% on a regular basis

## Skills

### Required
- Good Clinical Practice
- ICH Guidelines
- German
- English
- Oncology

### Nice to have
- oncology experience

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/DEU-Remote/Senior-CRA----Sponsor-dedicated---Home-Based-Germany_25114126-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)